Commission Implementing Decision (EU) 2017/2452

of 21 December 2017

renewing the authorisation for the placing on the market of products containing, consisting of, or produced from genetically modified maize 1507 (DAS-Ø15Ø7-1) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council

(notified under document C(2017) 9044)

(Only the Dutch, English and French texts are authentic)

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed1, and in particular Articles 11(3) and 23(3) thereof,

Whereas:

(1)

On 27 February 2015, Pioneer Overseas Corporation and Dow AgroSciences Ltd jointly submitted to the Commission an application, in accordance with Article 11 and Article 23 of Regulation (EC) No 1829/2003, for renewal of the authorisation for the placing on the market of foods, food ingredients, and feed containing, consisting of, or produced from genetically modified maize 1507 (hereinafter ‘maize 1507’). The scope of the renewal application also covers products other than food and feed containing or consisting of maize 1507. The scope of the application does not include cultivation.

(2)
The placing on the market of the products covered by the scope of the renewal application was previously authorised by two separate decisions: Commission Decision 2005/772/EC2 and Commission Decision 2006/197/EC3.
(3)
On 12 January 2017, the European Food Safety Authority (‘EFSA’) issued a favourable opinion in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003. Based on the data provided, it concluded4 that no new hazards or modified exposure and no new scientific uncertainties were identified for the application for renewal that would change the conclusions of the original risk assessment5 on maize 1507.
(4)

In its opinion, EFSA considered all the specific questions and concerns raised by the Member States in the context of the consultation of the national competent authorities as provided for by Articles 6(4) and 18(4) of Regulation (EC) No 1829/2003.

(5)

EFSA also concluded that the monitoring plan for environmental effects, consisting of a general surveillance plan, submitted by the applicant, is in line with the intended uses of the products.

(6)

Taking into account those considerations, the authorisation for the placing on the market of food and feed containing, consisting of, or produced from maize 1507 and of products consisting of it or containing it for other uses than food or feed, with the exception of cultivation, should be renewed.

(7)
A unique identifier has been assigned to genetically modified maize 1507, in accordance with Commission Regulation (EC) No 65/20046, by Decision 2005/772/EC. That unique identifier should continue to be used.
(8)
On the basis of the abovementioned EFSA opinion, no specific labelling requirements, other than those provided for in Articles 13(1) and 25(2) of Regulation (EC) No 1829/2003 and in Article 4(6) of Regulation (EC) No 1830/2003 of the European Parliament and of the Council7, appear to be necessary for the products covered by this Decision. However, in order to ensure the use of those products remains within the limits of the authorisation granted by this Decision, the labelling of the products containing or consisting of maize 1507, with the exception of food products, should contain a clear indication that the products in question are not intended for cultivation. Since an application for the authorisation for the placing on the market of maize 1507 seeds for cultivation is pending, this labelling requirement should only apply until that authorisation is granted.
(9)
The authorisation holders should submit joint annual reports on the implementation and the results of the activities set out in the monitoring plan. These results should be presented in accordance with Commission Decision 2009/770/EC8.
(10)

The EFSA opinion does not justify the imposition of specific conditions or restrictions for the placing on the market and/or the use and handling of the food and feed, including post-market monitoring requirements.

(11)

All relevant information on the authorisation of the products should be entered in the Community register of genetically modified food and feed referred to in Regulation (EC) No 1829/2003.

(12)
This Decision is to be notified through the Biosafety Clearing-House to the Parties to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity, pursuant to Articles 9(1) and 15(2)(c) of Regulation (EC) No 1946/2003 of the European Parliament and of the Council9.
(13)

The Standing Committee on Plants, Animals, Food and Feed has not delivered an opinion within the time limit laid down by its Chairman. This implementing act was deemed to be necessary and the chair submitted it to the appeal committee for further deliberation. The appeal committee did not deliver an opinion,

HAS ADOPTED THIS DECISION: